Certain medicinal products for external use

Certain medicinal products for external use are medicinal products for the treatment of mild diseases in man or animals in which the active ingredient(s) has a well-established medical use with a recognised effect and an acceptable safety margin.

Since the 1st of January 2017 it is no longer possible to apply for approval of new certain medicinal products for external use. New external products with active ingredient(s) of well-established medical use may instead be approved in accordance with the provisions on well-established use (WEU), so called bibliographical applications.

Those products that are already approved as certain medicinal products for external use are not affected by the changes; i.e. they remain certain medicinal products for external use.

Regulations

The regulation of certain medicinal products for external use is principally the same as for medicinal products in general, e.g. concerning variations, pharmacovigilance and product information.

Fees

The annual fee for a certain medicinal product for external use is 15 000 SEK.